Kornimate/medical-research-clean huggingface dataset:
childhood anesthesia and cognitive function

Conditions: Cognitive Deficits; Cognitive Ability, General

Summary: the purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction

contrary to a longstanding belief, anesthesia has lasting effects on the neonatal brain. in rats anesthesia causes death of brain cells, ill-timed conversion of stem cells to nerve cells and a certain kind of brain defect up to 8 months later. this brain defect is called a hippocampal deficit because it resembles the type of defect that people have when a structure in the brain called the hippocampus has been injured, removed or is no longer functioning. however, to date it is unknown if anesthesia given to human infants causes a lasting hippocampal deficit, which might manifest itself as memory problems and academic failure despite normal intelligence. the investigators will test the hypothesis that anesthesia for more than 2h given to children of less than 2 years of age without coexisting diseases of the brain or the heart causes long-term impairment of hippocampal function. using state of the art hippocampal and general brain function testing the investigators will compare hippocampal dependent and hippocampal independent memory as well as general cognitive function and emotional state in 10 year-old children that underwent at least a 2h anesthetic at less than 2 years with that of a matched control group that did not undergo an anesthetic.

Eligibility criteria:
inclusion criteria: * anesthesia at less than 2 years of age * anesthetic time greater than 2 hours * asa i or ii * induction with propofol or sevoflurane +/- n2o * maintenance with a volatile agent (sevoflurane, isoflurane, desflurane) +/- n2o exclusion criteria: * neurosurgery * known genetic syndrome * any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam) * low birthweight (\<25%ile) * gestational age , 36 weeks * color blindness * h/o cns disease * cancer * head trauma * congenital heart disease * asa iii or iv * intra-operative hypotension (\ 5 min) * bradycardia (\ 5 min) * hypoxemia (blood oxygen saturation \ 5 min) * hypercarbia (pco2 \> 60 mm hg \> 5 min) * dysthermia (deviation from 36.5 deg c by \> 1.5 deg c at any time) * puberty
orn study: curative treatment of osteoradionecrosis (orn) with hybrid bone substitution

Conditions: Mandible; Osteoradionecrosis

Summary: the main objective of the study is the cure of osteoradionecrosis (orn) at 12 months.


Eligibility criteria:
inclusion criteria: * adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic orn, radiologically confirmed, for which surgery is indicated * presence maximum of 2 outbreaks of orn * oncological remission of the original tumor site for 1 year and for 3 years if the orn is in the contact or close to the initial tumoral site * ecog performance status 0, 1 or 2 * orn symptomatic accessible to the conservation of at least one cortical mandibular basilar * signed informed consent exclusion criteria: * oncological treatment * haematologic background * current bone necrosis consecutive or concurrent to taking bisphosphonates * extension of orn does not allow the retention of a mandibular rod (bicortical form) * presence of fracture complicating orn * bisphosphonates during the last year * contraindications to the removal of iliac or sternum bone marrow * contraindication for general anesthesia

Keywords: mandibular osteoradionecrosis hybrid bone substitution calcium-phosphate ceramic biomaterial autologous bone marrow
effectiveness comparison between the drugs tobracort® and tobradex® in reducing the signs and symptoms of acute bacterial conjunctivitis

Conditions: Acute Bacterial Conjunctivitis

Summary: the primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical tobracort ® (tobramycin 0.3% dexamethasone + 1% - chemistry lab union) and tobradex ® (tobramycin 0.3% dexamethasone + 1 % - alcon lab), using the percentage of improvement (sustained response rate) at the end of treatment.

* evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; * observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Eligibility criteria:
inclusion criteria: * patients who agree with all study procedures and sign, by his own free will, ic; * adult patients, regardless of gender, ethnicity or social status, with good mental health; * patients who present at screening visit, a clinical picture of acute bacterial conjunctivitis diagnosed clinically. exclusion criteria: * patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis; * patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars; * patients with known hypersensitivity to any component of the study drug; * concomitant use of ocular medication other than the study; * patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion; * patients who have made use of systemic antibiotics in the 15 days preceding inclusion; * pregnant or lactating women; * being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days

Keywords: signs and symptoms of acute bacterial conjunctivitis
surgical strategy for head and neck adenoid cystic cancer

Conditions: Adenoid Cystic Carcinoma

Summary: to investigate the relationship between surgical margins and outcomes across different tumor stages, in order to provide evidence and guidance for refining stage-specific surgical approaches.

adenoid cystic carcinoma of the head and neck (hnacc) presents unique surgical challenges due to its propensity for perineural spread and proximity to critical craniofacial structures. while surgical resection remains the cornerstone of treatment, determining the optimal extent of resection to balance oncologic control and functional preservation requires further investigation. the investigator aimed to investigate the relationship between surgical margins and outcomes across different tumor stages, in order to provide evidence and guidance for refining stage-specific surgical approaches.

Eligibility criteria:
inclusion criteria: * patients who underwent surgical resection with curative intent and port. exclusion criteria: * underwent only biopsy, presented with distant metastases or second primary malignancies at initial diagnosis, had incomplete clinical or histopathologic data, or had histologic evidence of high-grade transformation.
study of ice application to reduce pain from arterial punctures

Conditions: Vessel Puncture Site Pain

Summary: this study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years old referred to the pulmonary function laboratory with a physician order for an arterial blood gas test were sought to complete the study exclusion criteria: * cold, bluish hands and fingers * diagnosis of raynaud's syndrome or scleroderma/crest syndrome * history or signs of dementia, confusion, or cognitive impairment * blindness * patients not fluent in the english language * non-palpable radial pulse in the wrist (necessitating brachial puncture)

Keywords: ice cryotherapy puncture pain
bone mineral density in pediatric epilepsy

Conditions: Epilepsy

Summary: what are the effects of the currently used aeds on bone mineralization in children and adolescents between the ages of 8 to 18? this is a pilot observational study using dexa scans to measure bone mineral density in 100 patients the primary objective is to collect preliminary data on bone mineral density, body weight, dietary calcium intake, and activity level.


Eligibility criteria:
inclusion criteria: * diagnosis of generalized or partial seizures with or without generalization or a diagnosis of generalized seizures as defined in the international league against epilepsy exclusion criteria: * steroid use * chronic disease other than epilepsy
a clinical study to evaluate the pharmacokinetics, efficacy, and safety of belumosudil in chinese adolescents with cgvhd who have had an inadequate response to glucocorticoids or other systemic therapies

Conditions: Chronic Graft Versus Host Disease

Summary: this is a single group, phase 4, single-arm post-marketing study for treatment. the purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in chinese adolescent participants (aged from 12 to less than 18) with cgvhd who have had an inadequate response to glucocorticoids or other systemic therapies. participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.


Eligibility criteria:
inclusion criteria: * participant must be 12 to less than 18 years of age at the time of signing the informed consent. * participant has undergone allogeneic hematopoietic stem cell transplantation (allo-hsct). * has active moderate to severe cgvhd. * has received at least one line of prior systemic therapy for cgvhd. * participant must receive a corticosteroid therapy for cgvhd with a stable dose for at least 2 weeks prior to the first dose of the imp. * has a lansky-play performance score of ≥60. * participants should have an expected survival of longer than 6 months. * body weight of 30 kg and above. * contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * the participant or their legally authorized representative (lar) must be capable of giving signed informed consent. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening. * received investigational systemic therapy for cgvhd within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter. * absolute neutrophil count (anc) \<1.0 × 10\^9/l. * platelet count \<50 × 10\^9/l. * alanine aminotransferase (alt) \>3× the upper limit of normal (uln), aspartate aminotransferase (ast) \>3 × uln. * total bilirubin (tbil) \>1.5 × uln (\>3 uln if gilbert's syndrome). * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m\^2 using the revised bedside schwartz formula . revised schwartz equation: crcl (ml/min/1.73 m\^2) = 0.413 × (height \[in cm\])/creatinine (in mg/dl) at screening visit. * participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
physical activity monitoring in myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs)

Conditions: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)

Summary: the investigators will assess the feasibility of activity monitoring armbands for continuous measurement of physical activity level in me/cfs patients, during 6 months follow-up. the main purpose is to assess if continuous measurement of activity level may be incorporated in outcome measures in future clinical interventional trials.

the purpose is to assess feasibility of activity monitoring armbands for continuous measurement of physical activity level in patents with myalgic encephalopathy/ chronic fatigue syndrome (me/cfs), during 6 months follow-up. the investigators will assess which physical activity parameters that best seem to reflect the participant's own perception of activity level, such as mean number of steps per 24 hours. the investigators will assess the agreement between continuous activity measurements by activity armbands, and self-reported questionnaires for health-related quality of life (sf-36 ver.2) and for me/cfs symptoms (dsq-sf). the investigators will assess the agreement between activity monitoring by armbands, and previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at 3 months and at 6 months follow-up.

Eligibility criteria:
inclusion criteria: * patients wit me/cfs according to canadian consensus criteria (2003) * me/cfs disease duration at least 2 years * mild, mild/moderate, moderate, moderate/severe and severe me/cfs may be included * signed informed consent exclusion criteria: * patients with fatigue, who do not meet the diagnostic "canadian" criteria (2003) for me/cfs * me/cfs disease duration \< 24 months * patients where the diagnostic workup uncovers other pathology as possible cause of symptoms * serious endogenous depression * lack of ability to complete the study including follow-up

Keywords: chronic fatigue syndrome myalgic encephalomyelitis me/cfs physical activity activity armband
efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with major depressive disorder (mdd) who have had an inadequate response to antidepressants alone

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with mdd who have had an inadequate response to antidepressants alone.


Eligibility criteria:
inclusion criteria: * written informed consent has been obtained. * written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, written authorization for use and release of health and research study information \[us sites\] and written data protection consent \[eu sites\]). * patient must be an outpatient at the time of visit 1 (screening). * patient meets the dsm-5 criteria for mdd based on scid-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at visit 1/screening. a diagnosis of mdd with psychotic features will be acceptable. * diagnosis of mdd confirmed through a formal adjudication process. * patient demonstrates ability to follow study instructions and likely to complete all required visits. * patient must have an inadequate response, as measured by the modified atrq, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode. * only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same adt dosing regimen through completion of visit 6/et. patients who are taking more than one antidepressant at screening, regardless of the indication, will need to discontinue all other antidepressants prior to visit 2 (baseline). * male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study. * women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to visit 2. exclusion criteria: * diagnosis of any current psychiatric diagnosis other than mdd (including those with current intellectual development disability) with the exception of specific phobias. * patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Keywords: mdd
scaling and root planing (srp) with and without minocycline hcl microspheres, 1 mg

Conditions: SRP; Minocycline HCl Microspheres; Biomarkers

Summary: the primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (srp) with and without minocycline hcl microspheres, 1 mg on periodontal pathogens and overall bacterial load. a randomized controlled clinical trial of a control (srp) group and an experimental (srp with minocycline hcl microspheres, 1 mg) group is planned. specific aim 1: evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period. specific aim 2: assess gingival crevicular fluid (gcf) and serum biomarkers of inflammation.

a randomized controlled clinical trial of a control (srp) group and an experimental (srp with minocycline hcl microspheres, 1 mg) group is planned. the intervention of minocycline hcl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. saliva samples, gcf, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). saliva will be analyzed for overall pathogen burden. gcf will be analyzed for interleukin (il)-1, il-6, and tumor necrosis factor alpha (tnf-α). serum will be analyzed for c-reactive protein (hscrp), haptoglobin (hp), hemoglobin a1c (hgb a1c), il-1, il-6, and tnf-α.

Eligibility criteria:
inclusion criteria: * male and female * at least 18 years of age * ada class iii-iv chronic periodontitis * scaling and root planing (srp) or localized srp * a minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant) exclusion criteria: * unable to comply with study protocol * completed treatment of scaling and root planing (srp) and/or localized srp within the last 6 months * cigarette use within the last year * ≥2 weeks of antibiotic use in the past three months. or antibiotic use in the last six weeks. * pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported) * diagnosed cardiac conditions (cardiovascular disease (cvd) or atherosclerotic vascular disease (asvd) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization * have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes hba1c \> 7, hiv, etc.) * tetracycline allergy * any medication that may impact periodontal conditions (phenytoin, calcium antagonists, cyclosporin, warfarin, or nsaids)
covid-19 vaccination in rheumatic disease patients

Conditions: Systemic Lupus Erythematosus; Sjogren's Syndrome; Inflammatory Myositis; Psoriatic Arthritis; Gout; Ankylosing Spondylitis; Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis); Osteoarthritis

Summary: the research is being done to study the immune responses to covid-19 vaccination in patients with rheumatic diseases.

because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mrna covid19 vaccines in these patients remains unknown. the goal is to study the immune response to covid-19 vaccination in patients with rheumatic diseases. blood samples collected before and longitudinally after mrna-based covid-19 vaccination (i.e., pfizer and moderna vaccines) will enable detailed immunological investigation of the interaction between covid-19 vaccination and rheumatic diseases. these efforts will provide novel insights into the covid-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.

Eligibility criteria:
inclusion criteria: * rheumatologist confirmed diagnosis of one of the following diagnoses: * systemic lupus erythematosus; * sjogren syndrome; * inflammatory myositis; * psoriatic arthritis; * osteoarthritis; * gout; * ankylosing spondylitis; * ibd-related arthritis. exclusion criteria: * active infection or untreated malignancy (other than skin cancer) at enrollment. * pregnancy
development and validation of the post-rt lars prediction model (portlars)

Conditions: Low Anterior Resection Syndrome; Radiotherapy; Rectal Cancer

Summary: bowel dysfunction is common after a restorative rectal cancer resection. neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. however, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. this multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the lars score, and to build a model that predicts long-term major lars in the early stage of follow-up. development and validation cohorts are enrolled from tertiary hospitals in china.


Eligibility criteria:
inclusion criteria: * curative low anterior resection for nonmetastatic rectal cancer * preoperative radiotherapy exclusion criteria: * death * metastasis or recurrence * postoperative radiotherapy * cognitive disorder * intestinal stoma * rectal cancer resection for \<12 months * stoma reversal for \<6 months

Keywords: bowel dysfunction low anterior resection syndrome radiotherapy rectal cancer
3d modeling of the cervico-facial region and cranial nerve tractography: imag 2 orl project

Conditions: Head and Neck Neoplasms; Congenital Abnormalities

Summary: 3d modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. indeed, these lesions are closely related to the cranial nerves and in particular nerve v (infratemporal fossa), nerve vii (temporal bone, parotido-masseter region), nerves ix, x, xi, xii and the chain cervical sympathetic (infratemporal and cervical regions). the development of a model of this region will therefore improve the surgical management of these children.

children aged 1 to 5 benefiting from a 3t magnetic resonance imaging (mri) at the necker enfants-malades hospital for their care, meeting the inclusion criteria and participating in the study, will benefit during their mri from the care, a sequence "research" tractography mri lasting 10 minutes. this sequence is already validated and proposed for tractography but in specialties other than pediatric ent. tractography techniques are mathematical algorithms based on the diffusion tensor (micro-movements of water molecules in tissues) to reconstruct the path of nerve fibers in each volume unit of the mri image (voxel). 3d modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. indeed, these lesions are closely related to the cranial nerves.

Eligibility criteria:
inclusion criteria: * benefiting from social security scheme. * informed consent signed by holders of parental authority and the investigator. * patient group: children aged 1 to 5 benefiting from a 3t mri at the necker enfants-malades hospital as part of the initial assessment of a tumor or a cervico-facial malformation. * control group: children aged 1 to 5 benefiting from a 3t mri at the necker enfants-malades hospital as part of the initial assessment of an ent pathology other than that of the patient group (examples: velar insufficiency, congenital deafness). exclusion criteria: child with a contraindication to mri: allergy to contrast product, pacemaker, starr edwards valves, stent placed for less than 6 weeks, vascular clips, contraindication to sedation.

Keywords: 3d modeling of the cervico-facial region tractography mri diffusion tensor magnetic resonance imaging (dt-mri) cranial nerve pediatrics